METHYLPREDNISOLONE tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)

থেকে পাওয়া:

Amneal Pharmaceuticals LLC

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Methylprednisolone tablets are indicated in the following conditions: 1.      Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.      Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis 3.      Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4.      Dermatologic Diseases Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Severe seborrheic dermatitis Exfoliative dermatitis Mycosis fungoides Pemphigus Severe psoriasis 5.      Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Drug hypersensitivity reactions Serum sickness Contact dermatitis Bronchial asthma Atopic dermatitis 6.      Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Keratitis Optic neuritis Allergic conjunctivitis Chorioretinitis Iritis and iridocyclitis 7.      Respiratory Diseases Symptomatic sarcoidosis Berylliosis Loeffler’s syndrome not manageable by other means Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8.      Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9.      Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10.  Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11.  Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12.  Nervous System Acute exacerbations of multiple sclerosis 13.  Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement. Systemic fungal infections and known hypersensitivity to components.

পণ্য সারাংশ:

Methylprednisolone Tablets USP, 4 mg are supplied as white, elliptical shaped, uncoated tablet debossed with “AA25” on one side and quadrisect scored on the other side. They are available as follows: Bottles of 100:                                      NDC 65162-871-10 Blister Packs of 21 counts:                   NDC 65162-871-40 Methylprednisolone Tablets USP, 8 mg are supplied as white, elliptical shaped, uncoated tablet debossed with “AA26” on one side and bisect scored on the other side. They are available as follows: Bottles of 25:                                        NDC 65162-980-29 Methylprednisolone Tablets USP, 16 mg are supplied as white, elliptical shaped, uncoated tablet debossed with “AA27” on one side and quadrisect scored on the other side. They are available as follows: Bottles of 25:                                        NDC 65162-982-29 Bottles of 50:                                        NDC 65162-982-05 Methylprednisolone Tablets USP, 32 mg are supplied as white, elliptical shaped, uncoated tablet debossed with “AA29” on one side and bisect scored on the other side. They are available as follows: Bottles of 25:                                        NDC 65162-984-29 Store at 20° to 25ºC (68° to 77ºF); excursions permitted between 15º to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature]. REFERENCES 1     Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases . Philadelphia: WBSaunders Company 1992:1050–1. 2     Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954–63. This product’s label may have been updated. For current full prescribing information, please visit www.amneal.com. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382220, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2021-00

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
AMNEAL PHARMACEUTICALS LLC
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METHYLPREDNISOLONE TABLETS, USP
RX ONLY
DESCRIPTION
Methylprednisolone tablets, USP contain methylprednisolone which is a
glucocorticoid.
Glucocorticoids are adrenocortical steroids, both naturally occurring
and synthetic,
which are readily absorbed from the gastrointestinal tract.
Methylprednisolone, USP
occurs as a white to practically white, odorless, crystalline powder.
It is sparingly soluble
in ethanol, in dioxane, and in methanol, slightly soluble in acetone,
and in chloroform,
and very slightly soluble in ether. It is practically insoluble in
water.
The chemical name for methylprednisolone is pregna-1, 4-diene-3,
20-dione, 11, 17, 21-
trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.5
g/mol. The structural
formula is represented below:
Each methylprednisolone tablet, USP for oral administration contains 4
mg, 8 mg, 16 mg
or 32 mg of methylprednisolone, USP. Inactive ingredients: anhydrous
lactose, calcium
stearate, lactose monohydrate and pregelatinized starch.
ACTIONS
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-
retaining properties, are used as replacement therapy in
adrenocortical deficiency
states. Their synthetic analogs are primarily used for their potent
anti-inflammatory
effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In
addition, they modify
the body’s immune responses to diverse stimuli.
INDICATIONS AND USAGE
Methylprednisolone tablets are indicated in the following conditions:
1. ENDOCRINE DISORDERS
Primary or secondary adrenocortical insufficiency (hydrocortisone or
cortisone is the
first choice; synthetic analogs may be used in conjunction with
mineralocorticoids where
applicable; in infancy mineralocorticoid supplementation is of
particular importance).
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. RHEUMATIC DISORDERS
As adjunctive therapy